A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00917306

Enrollment

102

Registered

2009-06-10

Start date

2009-06-30

Completion date

2009-09-30

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratosis

Keywords

Peplin, Actinic keratosis, PEP005

Brief summary

The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

Interventions

DRUGPEP005 Gel

0.05% two day treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient is male or female and at least 18 years of age. * Female patient must be of either: * Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus) * Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion criteria

* Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area. * Treatment with immunomodulators, interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks. * Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and 2 cm of the selected treatment area.

Design outcomes

Primary

Measure	Time frame
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)	57 days

Secondary

Measure	Time frame
Efficacy (complete and partial clearance of AK lesions)	57 days

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026